Paclitexel versus sirolimus-coated balloon in the treatment of coronary instent restenosis.

BACKGROUND: Few studies compared paclitaxel-coated balloon (PCB) versus sirolimus-coated balloon (SCB) in the treatment of drug-eluting stent (DES) instent restenosis (ISR). METHODS: Between November 5, 2009, and October 14, 2020, in our center 212 patients with first DES-ISR were treated with PCB (Restore®; Cardionovum GmbH, Bonn, Germany), whereas 230 patients were treated with SCB (Devoir®; MINVASYS SAS, Gennevilliers, France). Following a propensity matching, 186 patients were included into PCB group (PCB group), and in the SCB group (SCB group). The primary purpose of the study was the 1-year target lesion failure (TLF) rate, including cardiac death, target vessel-related myocardial infarction, and repeated target lesion or target vessel revascularization. RESULTS: Procedural success occurred in all cases. Fully optimal predilation (that is, balloon-to-stent ratio >0.91, time of DCB inflation >60 sec, and residual percent diameter stenosis after lesion preparation <20%) was observed more often in the SCB group (126 [68%] patients versus 106 [57%] patients; P=0.042). One-year TLF occurred in 29 (15.5%) patients in the SCB group and in 32 (17%) patients in the PCB group (OR=1.12 [0.65-1.95]; P=0.78). By logistic Cox regression analysis fully optimal predilation (OR=0.06; 95% CI: 0.01-0.21; P<0.001) but not DCB type (OR=0.74; 95% CI: 0.41-1.31; P=0.29) was independent predictor of 1-year TLF. CONCLUSIONS: The current study suggests that 1-year TLF is not statistically and clinically different in patients with DES ISR treated with a PCB and a SCB.

Long-term dual antiplatelet therapy and nuisance bleeding: impact on quality of life.

Long term dual antiplatelet therapy (LTDAPT), with ticagrelor 60 mg and low-dose aspirin, is indicated after acute coronary syndrome (ACS) for the secondary prevention of atherothrombotic events in high-risk patients with a history of ACS of at least 1 year. LTDAPT had a good tolerability and safety profile, but the risk of TIMI major bleeding was increased. However, even non-significant bleeding may be important because it has an effect on the quality of life and therefore may lead to treatment discontinuation. We, therefore, evaluated patients' experiences with LTDAPT and the impact of nuisance bleeding on quality of life and treatment adherence. We retrospectively reviewed 225 patients in follow-up after ACS with at least one high-risk condition, treated with ticagrelor 60 mg twice daily (after 90 mg twice daily for 12 months). The outpatient follow-up program after hospitalization provides a visit on day 30 after discharge, then after 3 months, continuing with six-monthly checks. We assessed the presence and intensity of bleeding, as well as health-related quality of life (HRQoL), at each visit. The TIMI score was used to determine the severity of the bleeding. Any overt bleeding event that did not meet the major and minor criteria was labeled "minimal" and could be framed as "nuisance bleeding." The HRQoL was assessed by the EuroQol-5 and Dimension (EQ-5D) visual analog scale (VAS) score. Minimal bleedings were present in 49 patients (21%), but only in one case (by decision of the patient) there was a cause for discontinuation of therapy. However, 39 (79%) subjects had asked for opinions on stopping the therapy during the telephone consultation. Factors influencing LTDAPT knowledge included access to medication counselling, engaging with information communicated during medication counselling, and access to timely, relevant and expert information and advice after discharge from the hospital. All adverse events, judged to be "not serious" in trials, may have an effect on the quality of life and therefore may lead to treatment discontinuation. The authors underline the importance of careful outpatient follow-up and ongoing counselling, to check out compliance and possible adverse effect of LTDAPT.

STENTYS coronary system: current status and future direction.

Stentys self-apposing stent was designed to face complex lesions in the precincts of percutaneous coronary interventions. Nitinol platform and disconnectable struts were designed to provide a complete apposition on the vessel wall in challenging lesions such as significant tapering, primary angioplasty in ST segment elevation myocardial infarction and bifurcation. Stentys X-position S is a sirolimus eluting stent with a novel delivery system aiming to improve positioning. Clinical trials showed good results in terms of procedural success rate, clinical outcome and short-term strut apposition. Nevertheless, Stentys stent did not show superiority over the conventional balloon-expandable stents in the clinical outcomes. Authors underlined the importance of a learning curve and an adequate training period to get familiar with the device's features. Future trials in an all-comer population using the novel X-Position S stent will confirm the preliminary findings and strengthen evidence in clinical practice.

Impact of a contrast media volume control device on acute kidney injury rate in patients with acute coronary syndrome.

BACKGROUND: The DyeVert™ system (Osprey Medical Inc., Minnesota, MN) may reduce contrast media (CM) volume during coronary procedures while maintaining fluoroscopic image quality. Here, we assessed whether the use of the DyeVert system reduces acute kidney injury (AKI) rate in patients with acute coronary syndrome (ACS) undergoing invasive coronary procedures. METHODS: ACS patients scheduled for coronary procedure from January 2017 to December 2019 were included. Two groups were identified: (a) Control group (n = 339), including patients in which a conventional manual injection syringe was used; and (b) DyeVert group (n = 112), in which CM injection was handled by the DyeVert™ system. A propensity score matching was performed to reduce the effect of treatment selection bias and potential confounders. In all cases, a low-osmolar, nonionic CM was administered. The primary objective was the rate of AKI, defined as a serum creatinine increase ≥0.3 mg/dl within 72 hr after CM exposure. RESULTS: CM volume was higher in the Control group than in the DyeVert group (130 [120-188] ml vs. 99 [69-136] ml; p <.001). In the DyeVert group the mean percent CM volume saved was 38 ± 13%. AKI occurred in 7/90 patients (8%) in the DyeVert group and in 17/90 (19%) patients in the Control group (odds ratio = 0.37; 95% confidence interval 0.14-0.95; p =.047). CONCLUSIONS: This preliminary result suggests that CM volume reduction obtained by the DyeVert™ system is an effective strategy to prevent AKI in ACS patients undergoing invasive procedure.

Sirolimus-eluting BiOSS LIM dedicated bifurcation stent in the treatment of unprotected distal left main stenosis.

BACKGROUND: Proximal optimization technique (POT) has been proposed to adapt the conventional drug-eluting stent (DES) with the fractal anatomy of the bifurcation. However, only few DES are labeled for post-expansion beyond 5.0 mm. Furthermore, recrossing in the side branch (SB) through the main vessel (MV) stent cells may be challenging. OBJECTIVES: To compare the sirolimus-eluting, balloon-expandable dedicated bifurcation stent BiOSS LIM DES versus the second generation DES in the treatment of distal unprotected left main coronary arteries (ULMCAs) lesions. METHODS: Forty-two consecutive patients with distal ULMCA lesions were treated with the BiOSS LIM (BiOSS LIM group) in our center. A matched-group of patients treated with second-generation DES was selected from our database (Control group). The primary endpoint was the procedural complication rate, including (a) SB occlusion, defined as intraprocedural TIMI flow grade <3 immediately after MV stenting; and/or (b) trouble in SB access, defined as the need of ≥2 guidewires or a failure to recross in the SB trough the MV stent cells. The need of POT in the two groups was also analyzed. RESULTS: The primary endpoint occurred in four (9.5%) patients in the BiOSS LIM group and in 13 (31%) in the Control group (p = 0.028; OR = 4.25; 95% confidence interval: 1.25-14.43). POT was performed more often in the Control group (71% vs. 35%; p = 0.004). CONCLUSIONS: Compared to conventional DES, the BiOSS LIM stent (1) facilitates SB recrossing and (2) fits well with the fractal anatomy of the left main bifurcation.

Role of optical coherence tomography in identifying sub-optimal stent positioning and predicting major adverse cardiac events in a comparative study with angiography: a CLIO-OPCI II sub-study.

BACKGROUND: Quantitative coronary angiography (QCA) is the gold standard for evaluating correct stenting, despite its limitation in recognizing features indicative of suboptimal deployment. This subanalysis of the CLI-OPCI II registry addressed the role of optical coherence tomography (OCT) to verify whether suboptimal OCT deployment occurs in the presence of an optimal angiographic result. PATIENTS AND METHODS: We retrospectively analyzed 125 lesions in the 105 patients with major adverse cardiac events of the CLI-OPCI II. Every lesion was evaluated with OCT and angiography, including visual and QCA assessment. Optimal angiographic result was defined as residual stenosis of less than 30% at QCA and absence of haziness at visual angiography. The following OCT features of suboptimal stenting were considered: edge dissection (linear rim of tissue with a width >200 µm), reference lumen narrowing (lumen area <4.5 mm in the presence of significant residual plaque adjacent to stent endings), and in-stent narrowing (minimum lumen area<4.5 mm). RESULTS: Among the 125 lesions, 105 showed an optimal angiographic result. At OCT, a suboptimal positioning was common (56%). In the group of optimal angiographic results, OCT showed a suboptimal deployment in 54% of cases. Minimum lumen area of less than 4.5 mm, distal and proximal reference narrowing, and distal edge dissections were found in 30, 25, 15, and 7% of cases, respectively. CONCLUSION: This substudy of the CLI-OPCI II showed that in patients with major adverse cardiac events, the presence of an optimal postintervention angiographic appearance with suboptimal OCT metrics is a frequent finding. Our data further support the effectiveness of OCT, which provide valuable information even in the presence of optimal poststenting angiographic results.

Prognostic Factors in Patients With Stemi Undergoing Primary PCI in the Clopidogrel Era: Role of Dual Antiplatelet Therapy at Admission and the Smoking Paradox on Long-Term Outcome.

BACKGROUND: Several clinical and laboratory variables have an impact on the prognosis of STEMI patients undergoing PPCI; however, little is known about the role of ongoing DAPT at the time of the event and the smoking status as prognostic factors affecting the outcome of these patients. METHODS AND RESULTS: Seven-hundred and thirteen consecutive STEMI patients undergoing PPCI, admitted to the S. Anna and S. Sebastiano Hospital (Caserta, Italy) and to the OLV Clinic (Aalst, Belgium), between March 2009 and December 2011, were retrospectively enrolled. Rescue PCI was the only exclusion criterion. Primary end-point was the combination of death for all causes, re-infarction, stroke, and target lesion revascularization (TLR). Patients already on DAPT at admission (26.4%) showed a significant increase in the event rate at univariate analysis (HR 2.34, CI 1.62-3.75, P < 0.05), while current smokers (56.5%) had a lower event rate, as compared to non-smokers (HR 0.67, CI 0.46-0.96, P < 0.05). In smoking patients already on DAPT at admission, a lower event rate was observed than in non-smoking patients on DAPT. Although, patients already on DAPT had a higher-risk profile (renal impairment, ongoing statin treatment, ST resolution <50%, and Killip class >1 were more frequently present than in patients not on DAPT), Cox regression analysis confirmed that both DAPT (HR 1.74, 95%CI 1.20-2.53, P < 0.01) and smoking status (HR 0.69, 95%CI 0.48-1.00, P < 0.05) retained their statistical significance, as they and were significantly associated with a worse and a better outcome, respectively, underlying their role as independent prognostic factors. CONCLUSIONS: Not being a current smoker and ongoing DAPT at admission, in patients with STEMI undergoing PPCI, represent independent negative prognostic value.

A Fatal Case of Endocarditis on CoreValve ReValving System Caused by Enterococcus faecium Complicated by Iatrogenic Pancytopenia and Subacute Disseminated Intravascular Coagulation.

During the past few years, a new and attractive approach--transcatheter aortic valve implantation (TAVI)--has been developed for patients who are symptomatic of aortic stenosis and, due to the high expected operative risk, would not be otherwise treated. Unfortunately, TAVI can result in endocarditis of the percutaneously implanted valve that may present atypically and cause delays in diagnosis and treatment. Herein, the case is described of a 79-year-old female affected by endocarditis on aortic valve percutaneously implanted caused by Enterococcus faecium, complicated by iatrogenic pancytopenia and subacute disseminated intravascular coagulation, that proved fatal at six months after TAVI.